UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1-2 study on preventive effect of compression therapy using newly developed glove for oxaliplatin-induced peripheral neuropathy in colorectal cancer chemotherapy
Title of the study (Brief title)	Study on preventive effect using newly developed glove for oxaliplatin-induced peripheral neuropathy
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Examination of preventive effect using newly developed glove for oxaliplatin-induced peripheral neuropathy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety and effectiveness of new development glove
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	newly developed glove
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients planning treatment with oxaliplatin 2) Patients who are over 20 years of age at consent acquisition 3) No gender 4) After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding
Key exclusion criteria	1) Patients with no peripheral neuropathy of Grade 1 or higher before starting the study 2) Patients who have not had a history of treatment with L-OHP in the past 3) Patients with disabilities or lesions difficult to wear gloves on the skin 4) Other Research Responsibilities (Sharing) Patients judged by doctors as inappropriate as subjects
Target sample size	30

Research contact person
Name of lead principal investigator	Akiyoshi Kanazawa
Organization	Shimane Prefectural Central Hospital
Division name	Department of Surgery
Address	Himebara 4-1-1. Izumo, Shimane
TEL	0853-22-5111
Email	kana@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Akiyoshi Kanazawa
Organization	Shimane Prefectural Central Hospital
Division name	Department of Surgery
Address	Himebara 4-1-1. Izumo, Shimane
TEL	0853-30-6590
Homepage URL
Email	kana@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Shimane Prefectural Central Hospital
Institute
Department

Funding Source
Organization	Shimane Prefectural Central Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 19 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2019 Year 02 Month 10 Day
Date trial data considered complete	2019 Year 02 Month 15 Day
Date analysis concluded	2019 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 23 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033900